A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.

Condition(s) targeted: Non-small Cell Lung Cancer

Intervention: erlotinib [Tarceva] (Drug); fusidic acid [Verutex] (Drug); erythromycin [Eritex] (Drug); Fisiogel (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Overall contact:
Please reference Study ID Number: ML21450, Phone: 888-662-6728 (U.S. Only), Email: genentechclinicaltrials@druginfo.com

This 3 arm study will compare the efficacy and safety of three different dermatological creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity of skin rash will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Official title: A Randomized, Open Label Study to Compare the Use of the Dermatological Creams Verutex, Eritex and Fisiogel in the Management of Skin Rash Associated With Tarceva Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer.

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Percentage of patients who develop skin rash

Secondary outcome:

Rate of treatment discontinuation due to skin rash

Time to appearance of skin rash

AEs

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- adult patients, >=18 years of age;

- locally advanced or metastatic non-small cell lung cancer (stage IIIB/IV);

- eligible to start treatment with Tarceva, or receiving Tarceva for <=5 days.

Exclusion Criteria:

- presence of skin rash or other signs of skin toxicity;

- treatment with any systemic or intranasal antibiotic within 7 days before

randomization;

- treatment with other topical formulation within 14 days before randomization;

- other anticancer therapy in addition to Tarceva.

Please reference Study ID Number: ML21450, Phone: 888-662-6728 (U.S. Only), Email: genentechclinicaltrials@druginfo.com

SAO PAULO 01308-000, Brazil; Recruiting

BELO HORIZONTE 30150-320, Brazil; Recruiting

SAO PAULO 01401-901, Brazil; Recruiting

RIBEIRÃO PRETO 14025-430, Brazil; Recruiting

SALVADOR 40170-070, Brazil; Not yet recruiting

GOIANIA 74075-040, Brazil; Recruiting

CURITIBA 80730-180, Brazil; Not yet recruiting

IJUÍ 98700-000, Brazil; Recruiting

FORTALEZA 60125-151, Brazil; Recruiting

PORTO ALEGRE 90430-090, Brazil; Not yet recruiting

SAO PAULO 01221-020, Brazil; Recruiting

RIO DE JANEIRO 22260-020, Brazil; Recruiting

RIO DE JANEIRO 22631-004, Brazil; Not yet recruiting

SAO PAULO 04039-901, Brazil; Recruiting

SALVADOR 41825-010, Brazil; Recruiting

ITAJAÍ 88301-220, Brazil; Not yet recruiting

SAO PAULO 05651-901, Brazil; Recruiting

TAGUATINGA 72115-700, Brazil; Not yet recruiting

NATAL 59062-000, Brazil; Not yet recruiting

SALVADOR 40110-150, Brazil; Recruiting

RECIFE 50070-170, Brazil; Not yet recruiting

FORTALEZA 60190-800, Brazil; Not yet recruiting

CURITIBA 80010-030, Brazil; Recruiting

BELO HORIZONTE 30150-281, Brazil; Recruiting

SAO PAULO 01227-200, Brazil; Not yet recruiting

CURITIBA 80810-050, Brazil; Not yet recruiting

DIVINÓPOLIS 35500-222, Brazil; Recruiting

SÃO PAULO 01323-000, Brazil; Recruiting

Starting date: March 2009
Ending date: November 2010
Last updated: October 15, 2009